FDA Social Media Guidance Controversy

FDAUnder the new FDA social media guidance, manufacturers would be responsible for monitoring their social media platforms for comments considered inaccurate, misleading or related to non approved or off label use.

They would also be liable when third party websites they have collaborated with publishes or do not filter articles, posts, ads or comments considered inaccurate, misleading or related to non approved or off label use.

All three major industry trade associations – the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Advanced Medical Technology Association (AdvaMed) warn FDA of significant flaws in the agency’s proposed regulations on the use of social media.

Their contention being that information and comments published online by third party comes under the first amendment and they should not have to monitor, correct or remove them even if they are misleading

The first amendment argument has been widely used to justify misleading information in non regulated industries but in the healthcare industry, misleading information, even by third party can have wide ranging consequences on the health of patients, raise false hope and create undue pressure by ill patients on doctors.

The other, untold part of the story is that social media is a cheap and effective way to do product testing and product development.  In this case, comments could provide insights into off label use and help manufacturers identify or isolate trends leading to new use for their products and could help them save millions of dollars in development and research cost.

The second contentious part of the proposed regulation relates to “Social Media Platforms with Character Space Limitations”, also called micro blogging platforms ( aka platforms like Twitter) where the limited number of characters does not allow for adequate disclosures within the post.

The three groups would like to see alternatives such as allowing a link or links to the disclosures

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